Impact of Accu-Chek 360 in Veterans With Type 2 Diabetes

NCT00824694 | Completed DMC

• 1 other identifier: Investigator Initiated
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 3

Brief Summary

To show that a structured treatment plan based upon Accu-Chek 360 View has a favorable effect on physician decision-making and HbA1c for patients on oral hypoglycemic agents (OHA) or insulin for type 2 diabetes (T2D). Hypothesis 1: Compared to controls, intervention subjects will undergo a greater number of medication changes and have a lower HbA1 at the conclusion of the study. Hypothesis 2: Higher rates of monitoring at entry will be associated with lower CHO consumption, lower percent body fat, higher medication compliance, and higher physical activity levels. Hypothesis 3: Patients with lower rates of monitoring at entry will have higher rates of depression, more likely to have an external locus of control, and express greater fear about self-testing.

Conditions

Type 2 Diabetes

Keywords

Glucose; Diabetes Mellitus, Type 2; HbA1c

Outcome Measures

Primary Outcomes (1)

• Principal endpoints will be measured 48 weeks after group assignment and include the number of medication changes and HbA1c. Interim analysis will include HbA1c measurement at 3 mont intervals.

  48 weeks

Secondary Outcomes (1)

• Secondary endpoints include changes in patient attitudes toward SMBG, daily carbohydrate consumption, physical activity level, BMI, and medication compliance (for subjects on OHA).

  48 weeks

Study Arms (2)

Intervention

ACTIVE COMPARATOR

The intervention will consist of targeted SMBG, provider training and patient education-all of which are focused on normalizing the most significant glucose abnormalities at any given time. SMBG will alternate between 2 strategies: glucose profiling and target monitoring. Intervention PCP's will use 380 View to identify a patient's most significant glucose elevations(s) and devise a treatment plan that includes drug type, dose increases, monitoring times, goal for the target, and stop criteria.

Other: Targeted Self-Monitoring Of Blood Glucose (SMBG); Other: Provider Training; Other: Patient Education

Control Arms

ACTIVE COMPARATOR

Subjects will repeat the dose titration cycle under the guidance of a case manager until the target is reached, maximal recommended doses of medications are used, or a stop criterion is met. They will then resume glucose profiling to identify the next target. This process is repeated until all targets reach their optimal value. Control patients will monitor and be treated in the customary manner.

Other: Targeted Self-Monitoring Of Blood Glucose (SMBG); Other: Provider Training; Other: Patient Education

Interventions

Targeted Self-Monitoring Of Blood Glucose (SMBG) OTHER

SMBG will alternate between 2 strategies: glucose profiling and target monitoring.

Control Arms; Intervention

Provider Training OTHER

Focused on normalizing the most significant glucose abnormalities at any given time.

Control Arms; Intervention

Patient Education OTHER

Focused on normalizing the most significant glucose abnormalities at any given time.

Control Arms; Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have a primary care provider
• Diabetes diagnosed after age 35
• Eat 3 meals daily and ≤ 1 snack
• If on OHA, have willingness to start insulin

You may not qualify if:

• Type 1 diabetes or DKA
• On insulin pump or CGM
• Preference for language other than English
• Can't or won't monitor
• Unfavorable occupation or living arrangements
• Terminal illness
• Active alcoholism or substance abuse
• Severe depression
• Chronic liver disease
• Pituitary or adrenal dysfunction
• Immunosuppression
• Hct \< 35
• Creatinine ≥ 2.5

Sponsors & Collaborators

• Biomedical Research Institute of New Mexico: lead
• New Mexico VA Healthcare System: collaborator
• Carl T. Hayden VA Medical Center: collaborator
• Southern Arizona VA Health Care System: collaborator

Study Sites (3)

Carl T. Hayden VAMC

Phoenix, Arizona, 85012, United States

Location

Southern Arizona VA Healthcare System

Tucson, Arizona, 85723, United States

Location

New Mexico VA Health Care System

Albuquerque, New Mexico, 87108, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Glen H Murata, M.D.

  New Mexico VA Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 16, 2009
• First Posted: January 19, 2009
• Study Start: March 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 23, 2011

Record last verified: 2011-06

Locations

US (3)